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NCT Number: NCT05742282

ASPIRE (Aub-haS2 Plus bIomaRkErs)

ASPIRE is a prospective, multicenter, observational study that will assess the performance of AUB-HAS2 to predict the occurrence of major adverse cardiovascular events 30-days after a non-cardiac surgery and the additional role of high-sensitivity troponin T and NT-ProBNP biomarkers in the accuracy of different event prediction indexes after non-cardiac procedures.

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Key information

Conditions

Perioperative Medicine

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Samaritano Paulista

São Paulo, Brazil

Location contact

Pedro de Barros e Silva, MD, MHS, PHD

CONTACT

About this study

Primary objectives:

Primary objective of the validation arm: to analyze the accuracy of the AUB-HAS2 index in predicting the occurrence of myocardial infarction, stroke and death within 30 days after non-cardiac surgeries.

Primary objective biomarker arm: to analyze the additional role of high-sensitivity troponin T and NT-ProBNP biomarkers in the accuracy of different event prediction indexes after non-cardiac surgeries.

Secondary objectives:

To analyze the potentially preventable factors related to adverse outcomes after non-cardiac surgeries in order to offer subsidies for more assertive guidelines regarding the implementation of perioperative protection strategies. Compare the performance of these scores with others that have already been validated (ACP and Lee - see Annex A).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 40 years, in the preoperative period of non-cardiac procedures, with expected hospitalization for at least 24 hours postoperatively.

Exclusion criteria

  • Refusal to sign the informed consent form.

Treatment and study plan

Primary outcomes

  1. RATE OF MAJOR ADVERSE CARDIOVASCULAR EVENTS

    Time frame: 30 days

    COMPOSITE OF DEATH, MYOCARDIAL INFARCTION AND STROKE

Secondary outcomes

  1. RATE OF MYOCARDIAL INJURY

    Time frame: 30 days

Study contacts

Contact information is provided by the study sponsor or research team.

PEDRO DE BARROS E SILVA, MD PhD

CONTACT

[email protected]

551128275000

Sponsors and collaborators

Lead sponsor

Hospital Samaritano Paulista

Other

Registry information

Official study title

Validation of the AUB-HAS2 Score in a Brazilian Population and Study of the Additional Impact of Biomarkers in Predicting Perioperative Risk

Acronym: ASPIRE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2023
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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